医療従事者の為の最新医療ニュースや様々な情報・ツールを提供する医療総合サイト

RIVA a Key Component of Licensed Manufacturing Process for Chemotherapy Drugs in Australia

2015年01月05日 PM11:37
このエントリーをはてなブックマークに追加


 

WINNIPEG, Manitoba

Intelligent Hospital Systems (IH Systems) today announced the Australian Therapeutic Goods Administration (TGA), that nation’s equivalent of the U.S. Food and Drug Administration, has approved a workflow process in which one of Australia’s largest pharmaceutical compounders will use RIVA technology to produce patient chemotherapy doses. This is the first time the TGA has approved a drug compounding process that includes a fully automated IV compounding system in a Current Good Manufacturing Practice (cGMP) facility.

“We are excited to demonstrate the benefits of integrating IV automation technology in compounding chemotherapy medications,” said Dr. Niels Erik Hansen, president and CEO of IH Systems. “This is an important recognition that the processes, safety features and airflow design of RIVA meet the strict requirements for sterile compounding in a cGMP environment.”

The TGA is part of the Australian government’s Department of Health and responsible for regulating therapeutic goods including prescription medicines and devices, among other things. IH Systems and the compounder worked together extensively on the necessary validation of the RIVA Chemotherapy system to demonstrate the technology and processes meet TGA’s stringent requirements. With TGA’s approval, the system is now in production manufacturing doses for Australia and New Zealand.

“This is a very important step forward in pharmaceutical compounding and represents the leading edge of integrating fully automated compounding into cGMP production processes,” said Dr. Hansen. “RIVA provides a technology platform that allows drug makers to maintain rigorous compounding standards while meeting customer and patient needs.”

The partnership is significant and may provide a model for future drug production in other highly regulated countries or compounding environments, Dr. Hansen added.

About Intelligent Hospital Systems

Founded in 2006, Intelligent Hospital Systems (IH Systems) is a medical device company focused on the design and development of automated solutions for the hospital environment. Based in Winnipeg, Manitoba, IH Systems manufactures RIVA, a fully automated IV compounding system that prepares medications for syringes and IV bags in an aseptic environment. Using RIVA, hospitals enhance patient safety, lower the cost-per-dose of medications, reduce their vulnerability to medication shortages and cut waste. For more information, visit http://www.intelligenthospitals.com/.

CONTACT

For IH Systems
Cookerly Public Relations
Cory Stewart,
404-816-2037
cory@cookerly.com

Related Posts Plugin for WordPress, Blogger...
 

同じカテゴリーの記事 

  • レスメド後援の研究で在宅酸素療法と在宅非侵襲的換気療法の併用が費用対効果の高いCOPD治療法であると判明
  • Takeda to Highlight Broad Oncology Portfolio and Pipeline Data at the American Society of Clinical Oncology (ASCO) and the Congress of the European Hematology Association (EHA) Annual Meetings
  • Cerveau Technologies, Inc.与日本东京都老人综合研究所签订研究协议
  • 继美国和英国之后,中国向Personalis, Inc.签发ACE©技术专利,扩大了其在国际上的知名度
  • セルヴォー・テクノロジーズが日本の東京都健康長寿医療センター研究所と研究契約を締結